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Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00698802
First received: June 16, 2008
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: EX1000
Drug: biphasic human insulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Fructosamine [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • FPG [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • 4-point SMPG profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events (including injection site reactions) [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Laboratory safety parameters (haematology, biochemistry and lipids) [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Physical examination and vital signs [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Total daily insulin dosages [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: EX1000
Treat-to-target titration scheme, s.c. injection
Active Comparator: B Drug: biphasic human insulin
Treat-to-target titration scheme, s.c. injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
  • Body Mass Index (BMI) less than or equal to 40.0 kg/m2
  • HbA1c less than or equal to 9.5%
  • FPG (SMPG) less than or equal to 12 mmol/L

Exclusion Criteria:

  • Treatment with more than 1IU/kg insulin daily
  • Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • Known or suspected allergy to trial products or related products
  • Receipt of any investigational drug within one month prior to this trial
  • Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698802

Locations
India
Vijayawada, India, 520002
South Africa
Johannesburg, Gauteng, South Africa, 2193
United Arab Emirates
Abu Dhabi, United Arab Emirates, 51900
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Kaa Meier Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00698802     History of Changes
Other Study ID Numbers: EX1000-1919
Study First Received: June 16, 2008
Last Updated: September 5, 2012
Health Authority: India: Ministry of Health
South Africa: Medicines Control Council
United Arab Emirates: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014